DETAILED ACTION
Status of the Claims
Claims 1-12 are currently pending and are examined herein.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 4 recites the limitation "the wells" in the claim. There is insufficient antecedent basis for this limitation in the claim or in the claim(s) from which it depends.
As per MPEP 2173: It is of utmost importance that patents issue with definite claims that clearly and precisely inform persons skilled in the art of the boundaries of protected subject matter. Therefore, claims that do not meet this standard must be rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph as indefinite. Further, as per MPEP 2173.02: If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. As currently written, the metes and bounds of the rejected claims are unascertainable for the reasons set forth above, thus the above claim(s) and all dependent claims are rejected under 35 USC 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Claim Rejections – 35 U.S.C. 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Lyons et al.
Claims 1-3 and 5-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lyons et al. (BMC Genomics, 2007, 8:64, doi:10.1186/1471-2164-8-64, cited in IDS of 02/23/2023) as evidenced by Affymetrix (GeneChip® Human Genome U133 Plus 2.0 Array datasheet, 2004, cited in IDS of 02/23/2023).
Regarding claims 1-3 and 5, Affymetrix discloses a kit comprising a cDNA micro- or nano-chip comprising a subset of genes or transcripts consisting of NP, AFP, DUSP6, B2M, SCYB5, FCN1, FTH1, HLA-DRB1, PPBP, FCGR3A, IGHG1, IGFBP1, WIPF1, MAGEA6, LPXN, CXCL1, GAGE2, CDKN1A, FCGR3A, TTC9, FYN, SERPINB2, CENPF, LIMS1, MDK, AX025098, A2M, CD74, IER3, HLA-B, ACTB, ANXA1, LAIR1, CD44, COL6A1, PRKCH, MAFB, EVI2A, and LAT.
Regarding claims 6-12, Lyons teaches a method for detecting a subset of messenger RNA (mRNA) in a subject method comprising:
obtaining a sample from the subject, wherein the sample comprises leukocytes isolated from whole blood (“RNA samples extracted from leucocyte subsets” as per the Results section on page 2);
isolating total RNA from the sample, wherein the total RNA comprises a subset of messenger RNA (mRNA) (e.g. “RNA was extracted using RNEasy mini kits (Qiagen) according to the manufacturer's instructions” as per the RNA extraction, labelling and microarray hybridisation section on pages 9-10);
determining the level of a subset of mRNA in the sample, wherein the subset of mRNA comprises NP, AFP, DUSP6, B2M, SCYB5, FCN1, FTH1, HLA-DRB1, PPBP, FCGR3A, IGHG1, IGFBP1, WIPF1, MAGEA6, LPXN, CXCL1, GAGE2, CDKN1A, FCGR3A, TTC9, FYN, SERPINB2, CENPF, LIMS1, MDK, AX025098, A2M, CD74, IER3, HLA-B, ACTB, ANXA1, LAIR1, CD44, COL6A1, PRKCH, MAFB, EVI2A, and LAT, further comprising producing cDNA from the isolated mRNA and detecting the subset of mRNA using a cDNA microarray (e.g. “For hybridisation to Affymetrix GeneChips 100 ng of total RNA was converted into double-stranded cDNA using the SMART cDNA synthesis kit” as per the Affymetrix analysis section on page 10).
Note that independent claim 1 recites that “a subset of genes or transcripts consisting of” the recited genes, and claim 7 recites that “a subset of mRNA in the sample, wherein the subset of mRNA consists of” the recited genes, both of which use the term “consisting of”, which is closed and excludes any element, step, or ingredient not specified in the subset of genes or transcripts. However, the claims use the transitional phrase “comprising” between the preamble and the body of the claims, which is inclusive or open-ended and does not exclude additional, unrecited elements or method steps, and therefore the micro- or nano-chip of claim 1 and the set of mRNAs determined in claim 7 may each reasonably have additional subsets of genes or mRNAs of essentially any number. Please see MPEP § 2111.03 for discussion of when a clause uses the term “consisting of” in a claim that uses the transitional phrase “comprising”.
Note that the Affymetrix GeneChip® Human Genome U133 Plus 2.0 Array, as per the Affymetrix datasheet, analyzes expression levels of over 47,000 transcripts, including 38,500 well-characterized human genes, and therefore there is reason to believe that the array is configured with capture oligonucleotides to detect essentially all known human genes, which would reasonably include those listed in claim 1. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). In the instant case, Affymetrix GeneChip® U133 Plus 2.0 Array advertises measuring 38,500 well-characterized human genes, which would reasonably include those listed in the claims, since they all appear to be known genes as suggested by inclusion of their NCBI GenBank® accession numbers in the specification. It is noted that a full listing of the genes detected by the Affymetrix GeneChip® Human Genome U133 Plus 2.0 Array can be downloaded in text format (file size >77 Mb) from https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GPL570
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
11,618,922 B2
Claims 1-3 and 5-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,618,922 B2 (the ‘922 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Conclusion
No claims are allowed.
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/JEREMY C FLINDERS/
Primary Examiner, Art Unit 1684